Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3

NCT ID: NCT02285166

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-21
• Study Completion Date: 2020-07-14

Brief Summary

The purpose of this survey is to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with and without omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical practice.

Detailed Description

This survey is planned to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical practice.

The incidence rate of CV events in the participants who are treated by the standard anti-hyperlipidemic therapies other than omega-3 fatty acid ethyl esters is investigated in this survey so as to compare the events rates between two participant groups just for information.

For adults, 2 g of omega-3 fatty acid ethyl esters is usually administered orally once daily immediately after meals. However, the dose can be increased up to twice daily (to a dose of 2 g) depending on participant's triglyceride (TG) level.

Conditions

Hyperlipidemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ever User of Omega-3 fatty acid ethyl esters 2 g

The usual adult dosage for oral use was 2 g of omega-3 fatty acid ethyl esters administered once daily or twice daily immediately after meals for treatment of hyperlipidemia. Participants received both interventions and standard antihyperlipidemic therapy as part of routine medical care.

Omega-3 fatty acid ethyl esters

Intervention Type: DRUG

Omega-3 fatty acid ethyl esters granular capsules

Never User of Omega-3 fatty acid ethyl esters 2 g

Participants received standard antihyperlipidemic therapy without omega-3 fatty acid ethyl esters 2 g as part of routine medical care.

Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).

Intervention Type: DRUG

Interventions

Omega-3 fatty acid ethyl esters

Omega-3 fatty acid ethyl esters granular capsules

Intervention Type: DRUG

Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).

Intervention Type: DRUG

Other Intervention Names

Lotriga granular capsules

Eligibility Criteria

Inclusion Criteria

Participants who meet all of the following criteria will be included in the survey:

1. Patients with hyperlipidemia on statin therapy

2. Outpatients

3. Male participants aged ≥ 50 years and female participants aged ≥ 60 years

4. Participants with fasting TG level ≥ 150 mg/dL (within 3 months prior to the start of the observation period)

5. Participants who have at least two of the following risk factors:

• Hypertension
• Type 2 diabetes mellitus
• Chronic kidney disease
• Prior history of myocardial infarction or angina pectoris
• Prior history of cerebral infarction
• Peripheral arterial disease

Exclusion Criteria

-Participants who meet any of the following criteria will be excluded from the survey:

1. Participants who have experienced coronary artery disease within 1 month prior to the start of the observation period

2. Participants who have experienced cerebrovascular disease within 1 month prior to the start of the observation period

3. Participants who have undergone heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention) within 1 month prior to the start of the observation period

4. Participants who plan to undergo heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention)

5. Patients with malignant tumors currently under treatment

6. Participants who have received eicosapentaenoic acid (hereinafter, EPA) products within 1 month prior to the start of the observation period, or participants who plan to receive treatment with EPA products after the start of the observation period

7. Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage)

8. Participants with prior history of hypersensitivity to any ingredients in omega-3 fatty acid ethyl esters (omega-3 fatty acid ethyl esters-treated participants only)

9. Participants with prior history of treatment with omega-3 fatty acid ethyl esters

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Osaka, , Japan

Tokyo, , Japan

Countries

Japan

References

Teramoto T, Ogawa H, Ueshima H, Okada Y, Haze K, Matsui S, Fujikawa K, Hashimoto T, Sakui S, Nishimura K, Kajita M, Horimoto A, Fernandez J. Effect of omega-3 fatty acids on cardiovascular events in high-risk patients with hypertriglyceridemia in Japan: a 3-year post-marketing surveillance study (OCEAN3 survey). Expert Opin Drug Saf. 2023 Jan;22(1):81-90. doi: 10.1080/14740338.2022.2094914. Epub 2022 Jul 8.

Reference Type: DERIVED

PMID: 35772177 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b60164db2bf003ab490aa

To obtain more information on the study, click here/on this link

Other Identifiers

JapicCTI-142680

Identifier Type: REGISTRY

Identifier Source: secondary_id

142-012

Identifier Type: -

Identifier Source: org_study_id